Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification

Overview

The primary objective of this study is to compare the efficacy of antecedent intravitreal anti-vascular endothelial growth factor therapy vs. Ozurdex in reducing post-cataract surgery related macular edema in patients with pre-existing diabetic macular edema.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 1, 2022

Detailed Description

In patients with pre-existing diabetic macular edema, anti-vascular endothelial growth factor therapy (Bevacizumab, ranibizumab, or aflibercept) will be compared to Ozurdex therapy administered 1 week prior to phacoemulsification cataract extraction. Spectral domain optical coherence tomography and visual acuity will be acquired at 1 week, 1 month, 2 months, and 3 months following cataract surgery.

Interventions

  • Drug: Bevacizumab
    • Bevacizumab
  • Drug: Ranibizumab
    • Ranibizumab
  • Drug: Aflibercept
    • Aflibercept
  • Drug: Ozurdex
    • Ozurdex

Arms, Groups and Cohorts

  • Active Comparator: Anti-vascular endothelial growth factor
    • Intravitreal Bevacizumab, Ranibizumab, or Aflibercept
  • Experimental: Ozurdex
    • Intravitreal Ozurdex

Clinical Trial Outcome Measures

Primary Measures

  • Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
    • Time Frame: 3 months after cataract surgery
    • Central foveal thickness will be measured in microns by spectral domain optical coherence tomography (Heidelberg) and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups

Secondary Measures

  • Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
    • Time Frame: 3 months after cataract surgery
    • Snellen visual acuity will be measured and converted into logMAR and compared to baseline at post-operative week 1, postoperative month 1, postoperative month 2, and postoperative month 3 for both anti-vascular endothelial growth factor and Ozurdex groups

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 years of age – Gender- All – Race- All – Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis) – >250 microns central foveal thickness – Able and willing to provide informed consent Exclusion Criteria:

  • Significant renal disease – A condition that in the opinion of the investigator would preclude participation – Participation in another investigational trial within 30 days of randomization – Application of focal macular laser within 120 days of enrollment – Administration of Iluvien implant within 3 years of enrollment – Administration of intravitreal triamcinolone within 3 months of enrollment – Administration of any anti-vascular endothelial growth factor agent within 30 days of enrollment – Known hypersensitivity to any of the investigational products – Blood pressure >180/110 – Women who are pregnant, lactating, or intend to become pregnant within 1 year of randomization – Vulnerable populations- including but not limited to wards of the state, cognitively impaired individuals, prisoners, institutionalized individuals – Individual is planning on moving within 6 months of study enrollment – Macular edema secondary to cause other than diabetic macular edema – Ocular condition that, in the opinion of the investigators, may affect course of macular edema during course of study (vein occlusion, uveitis, etc.) – Evidence of ocular infections – Evidence of uncontrolled glaucoma – Known hypersensitivity to any components of bevacizumab, ranibizumab, aflibercept, or Ozurdex

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bay Area Retina Associates
  • Collaborator
    • Allergan
  • Provider of Information About this Clinical Study
    • Principal Investigator: Caesar Luo, MD, FACS, Physician – Bay Area Retina Associates
  • Overall Official(s)
    • Caesar Luo, MD, Principal Investigator, Physician
  • Overall Contact(s)
    • Caesar Luo, MD, 9259436800, cluo@bayarearetina.com

References

Rauen PI, Ribeiro JA, Almeida FP, Scott IU, Messias A, Jorge R. Intravitreal injection of ranibizumab during cataract surgery in patients with diabetic macular edema. Retina. 2012 Oct;32(9):1799-803. doi: 10.1097/IAE.0b013e31824bebb8.

Furino C, Boscia F, Niro A, Giancipoli E, Grassi MO, D'amico Ricci G, Blasetti F, Reibaldi M, Alessio G. Combined Phacoemulsification and Intravitreal Dexamethasone Implant (Ozurdex(R)) in Diabetic Patients with Coexisting Cataract and Diabetic Macular Edema. J Ophthalmol. 2017;2017:4896036. doi: 10.1155/2017/4896036. Epub 2017 Aug 13.

Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552.

Yumusak E, Ornek K. Comparison of Perioperative Ranibizumab Injections for Diabetic Macular Edema in Patients Undergoing Cataract Surgery. J Ophthalmol. 2016;2016:7945619. doi: 10.1155/2016/7945619. Epub 2016 Jul 14.

Lim LL, Morrison JL, Constantinou M, Rogers S, Sandhu SS, Wickremasinghe SS, Kawasaki R, Al-Qureshi S. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery – preliminary 6 month results. Clin Exp Ophthalmol. 2016 May;44(4):233-42. doi: 10.1111/ceo.12720. Epub 2016 Mar 29.

Schmier JK, Halpern MT, Covert DW, Matthews GP. Evaluation of costs for cystoid macular edema among patients after cataract surgery. Retina. 2007 Jun;27(5):621-8. doi: 10.1097/01.iae.0000249577.92800.c0.

Hayashi K, Igarashi C, Hirata A, Hayashi H. Changes in diabetic macular oedema after phacoemulsification surgery. Eye (Lond). 2009 Feb;23(2):389-96. doi: 10.1038/sj.eye.6703022. Epub 2007 Oct 26.

Hartnett ME, Tinkham N, Paynter L, Geisen P, Rosenberg P, Koch G, Cohen KL. Aqueous vascular endothelial growth factor as a predictor of macular thickening following cataract surgery in patients with diabetes mellitus. Am J Ophthalmol. 2009 Dec;148(6):895-901.e1. doi: 10.1016/j.ajo.2009.07.014. Epub 2009 Oct 17.

Ferguson VM, Spalton DJ. Continued breakdown of the blood aqueous barrier following cataract surgery. Br J Ophthalmol. 1992 Aug;76(8):453-6. doi: 10.1136/bjo.76.8.453.

Dong N, Xu B, Wang B, Chu L, Tang X. Aqueous cytokines as predictors of macular edema in patients with diabetes following uncomplicated phacoemulsification cataract surgery. Biomed Res Int. 2015;2015:126984. doi: 10.1155/2015/126984. Epub 2015 Feb 25.

Patel JI, Hykin PG, Cree IA. Diabetic cataract removal: postoperative progression of maculopathy–growth factor and clinical analysis. Br J Ophthalmol. 2006 Jun;90(6):697-701. doi: 10.1136/bjo.2005.087403. Epub 2006 Mar 15.

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